Strategies of Revascularization in Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Multivessel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment elevation myocardial infarction (STEMI) and has been associated to a worse prognosis. Multivessel revascularization offers a myriad of potential advantages as enhance of the collateral blood flow, greater myocardial salvage, the stabilization of other lesions that can be potentially vulnerable, and the achievement of a complete revascularization, factor that is associated with a better prognosis. On the other hand, the prolongation of procedural duration, the hazard of contrast induced nephropathy and the peri-procedural complications can limit the widespread of this practice.

To date, very few observational studies have focused in the multivessel revascularization with disparity of results. Whereas ones have observed an increase of adverse cardiovascular events and thus not recommend it, others have shown neutral results.

Stress echocardiography has been shown to be an adequate technique for the diagnosis of coronary artery disease and could be an appropriate tool for selecting the lesions that need to be revascularized because they induce large areas of ischemia. However, this technique has also limitations like the high operator-dependence.

Therefore, the investigators sought to study if the complete multivessel revascularization of patients with STEMI treated by means of primary percutaneous coronary intervention (PCI) has an impact on prognosis compared to a strategy of treating only those non-culprit lesions that produce large areas of ischemia in a stress test.

Detailed Description

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Conditions

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Myocardial Infarction Angioplasty, Transluminal, Percutaneous Coronary Echocardiography, Stress

Keywords

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myocardial infarction primary angioplasty multivessel disease stress echocardiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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complete multivessel revascularization

Group Type EXPERIMENTAL

complete multivessel revascularization

Intervention Type PROCEDURE

After a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission

stress echo guided revascularization

Group Type ACTIVE_COMPARATOR

stress echocardiography and revascularization if required

Intervention Type PROCEDURE

after successful primary PCI, this group will undergo a stress echo to evaluate the significance of non-culprit lesions. If large area of ischemia is demonstrated, the artery supplying that are will be revascularized.

Interventions

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complete multivessel revascularization

After a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission

Intervention Type PROCEDURE

stress echocardiography and revascularization if required

after successful primary PCI, this group will undergo a stress echo to evaluate the significance of non-culprit lesions. If large area of ischemia is demonstrated, the artery supplying that are will be revascularized.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Typical chest pain lasting \>30 minutes with ST-segment elevation \>=1mm in \>=2 contiguous ECG leads or left bundle branch block and presentation \< 48 hours since symptom onset.
* Patients undergoing rescue PCI
* Patients with effective lysis and coronary angiography in less than 24 hours
* Presence of other lesion \>=70% in a non-culprit artery.
* Informed consent

Exclusion Criteria

* Significant left main disease
* Lesions in vessels \< 2 mm
* Lesions in branches of a main epicardial coronary artery and short irrigation territory
* Previous coronary artery bypass graft (CABG)
* Any coronary intervention in the previous month
* Cardiogenic shock
* Anatomic features no suitable for coronary intervention
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rodrigo Estévez-Loureiro

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodrigo Estevez-Loureiro, MD

Role: PRINCIPAL_INVESTIGATOR

Interventional Cardiology. Complejo Hospitalario Universitario A Couna